Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector

NCT06469541 | Completed

• 1 other identifier: M-877PAY-UK-2008
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing PCO (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL, Bi-Flex 877PAY (Medicontur).

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Primary objective

  To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation

  12 months after IOL implantation

Secondary Outcomes (1)

• Secondary onjective

  12 months after IOL implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The enrolled subjects will be the patients who underwent cataract surgery in one or both eyes and who were implanted with Bi-Flex 877PAY IOL mono- or bilaterally. For evaluation of records consecutive implanted patients with regular post-operative visits over a 12 months period will be included.

You may qualify if:

• Male or female patients who underwent cataract surgery in one or both eyes and who were implanted with Bi-Flex 877PAY IOL mono- or bilaterally.
• Patients with regular post-operative visits over 12 months period after surgery.
• Patients of any age above 18 years and any medical history who are eligible according the investigator's decision.

You may not qualify if:

• preoperative corneal astigmatism \> 1.5 D
• uncontrolled diabetic retinopathy
• iris neovascularisation
• serious intraoperative complications

Sponsors & Collaborators

• Medicontur Medical Engineering Ltd: lead

Study Sites (1)

NHS Ayrshire and Arran

Ayr, Scotland, KA7 2SP, United Kingdom

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Sathish Srinivasan, Prof.

  NHS Ayrshire and Arran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 21, 2024
• Study Start: April 11, 2023
• Primary Completion: July 31, 2023
• Study Completion: December 1, 2023
• Last Updated: June 21, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)